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SCLC,Extensive StagePhase 1/2NCT05505825

A Study of AK104 in Combination With Chiauranib in Patients With Extensive Stage Small Cell Lung Cancer

A Phase 1/2 study testing AK104 IV infusion；Chiauranib oral in people with SCLC,Extensive Stage, run by Akeso at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Phase Ib/II open label,international multicentre study to evaluate the efficacy and safety of anti-PD-1 and CTLA-4 bispecific antibody AK104 in combination with Chiauranib in Patients with Extensive Stage Small Cell Lung Cancer Who Failed First-line Platinum-based Chemotherapy in Combination with PD1/PDL1 Inhibitors Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
SCLC,Extensive Stage
What is being tested?
AK104 IV infusion；Chiauranib oral
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
7 sitesin 2 countries
Study dates
26 Aug 2022to 31 Jul 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject must sign the written informed consent form (ICF) voluntarily.
  • Aged ≥ 18 to ≤ 75 years.
  • Eastern Cooperative Oncology Group(ECOG) performance status score of 0 or 1.
  • Life expectancy≥ 3 months.
  • Histologically or cytologically confirmed ES-SCLC according to the Veterans Administration Lung Study Group(VALG) stage.
  • Phase Ib and II: Subjects with ES-SCLC who have failed prior first-line platinum-based chemotherapy in combination with PD1/PDL1 inhibitors will be enrolled.
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  • At least 1 measurable lesion per RECIST v1.1, which is applicable for repeated accurate measurement. Brain metastatic lesions are not considered target lesions.
  • Adequate organ function.
  • Women of childbearing potential must have a negative urine or serum pregnancy test
  • If a nonsterile male subject has sexual intercourse with a female partner of childbearing potential, he must use an effective method of contraception from the start of screening until Day 120 after the last dose; it should be discussed with the Investigator whether contraception should be discontinued after this time point.
  • Subjects must be willing and able to comply with the scheduled visits, treatment regimens, laboratory tests, and other requirements in the study.

Who cannot join

  • Malignancies other than SCLC within 3 years prior to enrollment. However, subjects with other malignancies that have been cured are eligible.
  • Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study.
  • Subjects whose imaging at screening shows that the tumor encircles important blood vessels or has significant necrosis and cavitation, and the subjects'participation is associated with a risk of hemorrhage.
  • Tumor invasion of surrounding vital organs and blood vessels.
  • Subjects who had active autoimmune disease that required systemic treatment in the past two years.
  • Subjects with prior history of non-infectious pneumonitis/interstitial lung disease requiring systemic glucocorticoid therapy or with non-infectious pneumonitis at present.
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  • Presence of metastases to brainstem, meninges and spinal cord, or spinal cord compression.
  • Subjects with pleural effusion, pericardial effusion, or ascites that are clinically symptomatic or require drainage.
  • Subjects with unresolved toxicity due to prior anti-tumor therapy, defined as failure to recover to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE) v5.0 Grade 0 or 1 (except for alopecia) or to the levels specified in the inclusion/exclusion criteria.
  • Subjects who cannot swallow pills, and who have malabsorption syndrome, or any condition affecting gastrointestinal absorption. Subjects with active or prior history of definite inflammatory bowel disease.
  • Subjects with a history of immunodeficiency; a positive human immunodeficiency virus (HIV) antibody test; and current long-term use of systemic corticosteroids or other immunosuppressants.
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • Subjects who had major surgical procedure or serious trauma within 30 days prior to the first dose, or a major scheduled surgery within 30 days after the first dose; subjects who had minor local surgery within 3 days prior to the first dose.

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

Australia6 sites

  • Flinders Medical Centre

    Bedford Park, South Australia

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, Victoria

  • Icon Cancer Centre

    South Brisbane, Queensland

  • Sunshine Hospital

    St Albans, Victoria

  • Westmead Hospital

    Westmead, New South Wales

  • Princess Alexandra Hospital

    Woolloongabba, Queensland

Other trials in Australia

China1 site

  • Jilin Province Cancer Hospital

    Changchun, Jilin, 130000

Other trials in China

About this study

Official title: A Phase Ib/II Clinical Study of Anti-PD-1 and CTLA-4 Bispecific Antibody, Cadonilimab(AK104), in Combination With Chiauranib in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer Who Failed First-line Platinum-based Chemotherapy in Combination With Programmed Cell Death-1(PD1)/Programmed Cell Death Protein Ligand-1(PDL1) Inhibitors

A Phase Ib/II open label,international multicentre study to evaluate the efficacy and safety of anti-PD-1 and CTLA-4 bispecific antibody AK104 in combination with Chiauranib in Patients with Extensive Stage Small Cell Lung Cancer Who Failed First-line Platinum-based Chemotherapy in Combination with PD1/PDL1 Inhibitors

Read the detailed description

Small cell lung cancer (SCLC) consists 15% of the lung cancer.Because of the high malignancy, poor cell differentiation, and rapid proliferation of SCLC, 65% of the patients were in the extensive stage at their first presentation in the hospital with a very poor prognosis. There were few options of second-line therapies for patients who experienced progress disease during or after the end of first-line platinum-based regimens. Several studies showed that PD-1/PD-L1 inhibitors had synergistic anti-tumor effects with anti-vascular endothelial growth factor(VEGF) agents, i.e., PD-1/PD-L1 inhibitors could restore the anti-tumor effect of the immune system by blocking PD-L1, and anti-VEGF agents could improve the efficacy of the former by blocking the immunosuppressive effect of VEGF and promoting the infiltration of T cells in tumor tissues. Immunotherapy in combination with antiangiogenic therapy may become a trend in the treatment of extensive stage small cell lung cancer(ES-SCLC). The aim of this international multicentre phase Ib/II trial is to evaluate the efficacy-objective response rate according to RECIST criteria and safety-incidence and severity of adverse events.The patients' recruitment timeframe is set at 16 months and approximately 42 patients will be included.

Being tested
AK104 IV infusion；Chiauranib oral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK104 IV infusion；Chiauranib oralDrug

    AK104 IV infusion once every 3 weeks；Chiauranib once a day oral

Study groups in NCT05505825
Study groupRoleWhat they receive
AK104 once every 3 weeks and Chiauranib once a dayExperimentalSubjects receive AK104 once every 3 weeks plus Chiauranib once a day until intolerable toxicity, no more clinical benefit as judged by the investigator, or completion of 24 months of treatment, or meeting other criteria for termination of treatment in the protocol, whichever occurs first.
Receives: Drug: AK104 IV infusion；Chiauranib oral

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    ORR is proportion of subjects with complete response(CR) or partial response(PR), based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1

    Measured: Up to approximately 2 years

  2. Incidence and severity of adverse events(AEs)

    Incidence and severity of AEs is aim to evaluate the safety of AK104 in combination with Chiauranib.

    Measured: Up to approximately 2 years

Secondary outcomes (7)

  1. Disease control rate (DCR)

    Disease control rate (DCR) is defined as the proportion of subjects achieving a best of response(BOR) of confirmed CR and PR and stable disease(SD) per RECIST v1.1.

    Measured: Up to approximately 2 years

  2. duration of response (DoR)

    Duration of response (DoR) is defined as the period from the first documentation of confirmed response (CR or PR) to the first documentation of progressive disease(PD) (as per RECIST v1.1) or death due to any cause, whichever occurs first.

    Measured: Up to approximately 2 years

  3. time to response (TTR)

    Time to response (TTR) is defined as the time from the first dose of investigational products until the first confirmation of CR or PR.

    Measured: Up to approximately 2 years

  4. progression-free survival (PFS)

    Progression-free survival (PFS) is defined as the time from the first dose of investigational products until documentation of PD (as per RECIST v1.1) or death due to any cause, whichever occurs first.

    Measured: Up to approximately 2 years

  5. overall survival (OS)

    Overall survival (OS) is defined as the time from the first dose of investigational products until death due to any cause.

    Measured: Up to approximately 2 years

  6. Pharmacokinetics(PK) profiles

    Serum concentrations of AK104 and plasma concentrations of Chiauranib in individual subjects at different time points after administration of AK104 in combination with Chiauranib.

    Measured: Up to approximately 2 years

  7. Immunogenicity assessment

    The immunogenic potential of AK104 in combination with Chiauranib will be assessed by summarizing the number and percentage of subjects with detectable antidrug antibody(ADA).

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2022
  2. Study start26 Aug 2022
  3. Primary completion19 Jul 2024
  4. Study completion31 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05505825
Sponsor's protocol ID
AK104-212
Status last verified
Mar 2025
First submitted
16 Aug 2022
Last updated
12 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AK104 IV infusion；Chiauranib oral in people with SCLC,Extensive Stage, run by Akeso at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Australia, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05505825.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.

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